Otsuka enters deal with Mylan to bring MDR TB drug to India

The Drug Controller General of India has granted Mylan’s subsidiary approval for the drug, according to a release by the company. The drug, delamanid, was discovered and developed by Otsuka.Prabha Raghavan | ET Bureau | August 25, 2017, 05:10 IST

NEW DELHI: Japanese drug maker Otsuka Pharmaceutical has granted US pharmaceutical firm Mylan’s subsidiary an exclusive licence to supply to India and South Africa a drug to treat patients with pulmonary multi-drug resistant tuberculosis (MDR TB). The agreement is expected to speed up India’s access to the potentially life-saving drug, which had not been made available in the country despite Otsuka having received a patent for it back in 2011.

The Drug Controller General of India (DCGI), India’s apex drug regulator, has granted Mylan’s subsidiary approval for the drug, according to a release by the company. The drug, delamanid, was discovered and developed by Otsuka.

India, with a TB burden of around 2.8 million in 2015, accounts for a little over a quarter of the global TB burden and has the largest number of MDR TB cases worldwide, according to the World Health Organisation (WHO).

At least 400 patients in India will likely have access to delamanid as part of the government’s Conditional Access Programme in the next six months, a senior health ministry official told ET on condition of anonymity. Mylan is expected to provide these 400 doses to the government for free.

DCGI told the health ministry sometime last week that delamanid could now be included in the country’s conditional access programme, another senior ministry official told ET.

The Revised National Tuberculosis Control Program (RNTCP) will now begin drafting the protocol to administer delamanid with other drugs to patients with MDR TB and identify sites where the drug will be rolled out, said the official.

“RNTCP will prepare its guidelines and delamanid will be rolled out depending on its preparation activity and how fast Mylan can provide the drugs,” the official told ET.

Mylan will use clinical data from these sites to conduct a post marketing survey, after which DCGI may give them permission to introduce it in the private market, according to the official.

ET is awaiting Mylan’s responses to queries about the development.

Generic drug makers cannot compete with Otsuka’s drug because of its agreement with Mylan and its patent on delamanid—valid until 2022, according to the Indian Patent Office. This could make the drug too expensive for India if it has to pay for it later, said Leena Menghaney, South Asia Head for MSF’s Access Campaign.

“All developing countries, including India, will be tied to a $1,700 price per six month treatment course for delamanid as long as generics don’t supply. We would prefer that the Indian government issue a compulsory license or the drug is licensed for the period that it is patented under the patent pool,” she told ET.

The government intends to enter into discussions with Mylan to ensure that delamanid remains affordable to India going forward, according to Soumya Swaminathan, Director General, Indian Council of Medical Research.

“As of now, there is no thinking about compulsory licencing for the drug, but there will have to be a dialogue on how it is going to remain sustainable for the future. This dialogue will begin fairly soon,” she told ET.

The only other drug available in India for patients with MDR TB, a growing issue in the country, is bedaquiline by Johnson & Johnson. This drug was introduced last year and is also supplied to a limited number of patients through the government's conditional access program.